Used as monotherapy as an adjunct to diet and exercise for management of type 2 (noninsulin-dependent) diabetes mellitus in patients whose hyperglycemia cannot be controlled with diet and exercise alone.
Used as second-line therapy in combination with one or more other oral antidiabetic agents or insulin as an adjunct to diet and exercise in patients with type 2 diabetes mellitus in whom adequate glycemic control cannot be achieved with oral antidiabetic agent monotherapy.
Alternative therapy in some type 2 diabetic patients being treated with insulin or other antidiabetic agent(s). Useful in combination with insulin to improve glycemic control and/or decrease insulin dosage in some type 2 diabetic patients.
Not effective as sole therapy in patients with type 1 diabetes mellitus or diabetic acidosis, ketosis, or coma; insulin is necessary. (See Contraindications under Cautions.)
Not routinely recommended in hospitalized patients with diabetes mellitus. Long duration of action precludes rapid dosage adjustments. Increased risk of hypoglycemia in hospitalized diabetic patients with irregular eating patterns.
Dosage and Administration
General
Adjust dosage according to severity of disease, tolerance, and blood glucose determinations.
Monitor regularly (e.g., blood glucose concentrations) to determine minimum effective dosage and to detect primary failure or secondary failure. (See Loss of Glycemic Control under Cautions.)
Monitor glycosylated hemoglobin (HbA1c) to determine patient’s continued response to therapy.
Administration of loading dose is not recommended.
During transfer from insulin therapy, patients should test their blood glucose concentrations ≥3 times daily. (See Advice to Patients.) Early hypoglycemia (≤24 hours) following transfer from intermediate or long-acting insulins usually results from insulin carry-over rather than from chlorpropamide. In some patients, consider hospitalization during transition period.
Administration
Oral Administration
Administer orally as a single daily dose each morning with breakfast. May administer in 2 divided doses if GI intolerance occurs.
Dosage
Adults
Diabetes Mellitus
Initiation
Oral
Initially, 250 mg daily.
Initial Dosage in Patients Transferred from Other Oral Antidiabetic Agents
Oral
Initially, 250 mg daily. May abruptly discontinue the other oral antidiabetic agent.
Initial Dosage in Patients Transferred from Insulin
Insulin requirements >40 units daily: Initially, 250 mg daily; reduce daily insulin dosage by 50% for first few days. Subsequently, adjust insulin dosage according to therapeutic response.
Titration and Maintenance Dosage
Oral
5–7 days after initiating therapy, titrate dosage in increments or decrements of ≤50–125 mg daily at 3- to 5-day intervals to achieve adequate glycemic control; more frequent dosage adjustments usually undesirable.
Usual maintenance dosage is 100–500 mg daily. Patients not responding to 500 mg daily are unlikely to respond to higher dosages.
Prescribing Limits
Adults
Diabetes Mellitus
Oral
Maximum 750 mg daily.
Special Populations
Hepatic Impairment
Use conservative initial and maintenance dosages to avoid hypoglycemia. (See Hepatic Impairment under Cautions.)
Renal Impairment
Use conservative initial and maintenance dosages to avoid hypoglycemia. (See Renal Impairment under Cautions.)
Geriatric Patients
Initially, 100–125 mg daily. Use conservative initial and maintenance dosages to avoid hypoglycemia. (See Geriatric Use under Cautions.)
Debilitated or Malnourished Patients
Use conservative initial and maintenance dosages to avoid hypoglycemia.
Pituitary or Adrenal Insufficiency
Use conservative initial and maintenance dosages to avoid hypoglycemia.
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